The FDA has approved guselkumab for the treatment of active psoriatic arthritis, making it the first selective IL-23 Inhibitor approved to treat the condition, according to a release from the manufacturer.
The approval comes after the completion of two pivotal phase III trials showing that the treatment improved symptoms in joints, skin, and soft tissue in adults with psoriatic arthritis, the release said. The trials compared the treatment to placebo, with the results published in The Lancet.” Those results showed patients in the drug arm 52 and 64% of patients achieving an ACR20 response compared to 22 and 33% in patients treated with placebo between the two studies, respectively.
Patients in the drug arm also showed better results with symptoms including skin manifestations, physical functioning as measured by the HAQ-DI and SF-36 Physical Component Summary Score, and fatigue, according to the release.
“Psoriatic arthritis is a complex multifaceted disease, and, for many patients, additional biologic options are very much needed,” said Philip J. Mease, MD, Director of Rheumatology Research at the Swedish Medical Center, in the release. “Today’s approval is exciting for both patients and their physicians, as there is now a new approach available to help manage the symptoms of active psoriatic arthritis that patients face day to day.”
With the approval, guselkumab can be administered as a 100 mg subcutaneous injection every eight weeks and can be combined with a Disease Modifying Anti-Rheumatic Drug.